HYDRALAZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)

Available from:

Cadila Pharmaceuticals Limited

INN (International Name):

HYDRALAZINE HYDROCHLORIDE

Composition:

HYDRALAZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Essential hypertension, alone or as an adjunct. Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

Product summary:

HydrALAZINE Hydrochloride Tablets USP are available as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured By: Cadila Pharmaceuticals Limited 1389 Trasad Road, Dholka, District - Ahmedabad, Gujarat, INDIA.   Revised: November 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDRALAZINE HYDROCHLORIDE - HYDRALAZINE HYDROCHLORIDE TABLET
CADILA PHARMACEUTICALS LIMITED
----------
RX ONLY
DESCRIPTION
HydrALAZINE hydrochloride USP, is an antihypertensive, for oral
administration. Its
chemical name is 1-hydrazinophthalazine monohydrochloride, and its
structural formula
is:
C H N HCl M.W. 196.64
HydrALAZINE hydrochloride USP is a white to off-white, odorless
crystalline powder. It is
soluble in water, slightly soluble in alcohol, and very slightly
soluble in ether. It melts at
about 275°C, with decomposition.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg
HydrALAZINE
hydrochloride USP. Tablets also contain mannitol, microcrystalline
cellulose, sodium
starch glycolate, stearic acid and FD&C Yellow #6.
CLINICAL PHARMACOLOGY
Although the precise mechanism of action of hydrALAZINE is not fully
understood, the
major effects are on the cardiovascular system.
HydrALAZINE apparently lowers blood pressure by exerting a peripheral
vasodilating
effect through a direct relaxation of vascular smooth muscle.
HydrALAZINE, by altering
cellular calcium metabolism, interferes with the calcium movements
within the vascular
smooth muscle that are responsible for initiating or maintaining the
contractile state.
The peripheral vasodilating effect of hydrALAZINE results in decreased
arterial blood
pressure (diastolic more than systolic); decreased peripheral vascular
resistance; and an
increased heart rate, stroke volume, and cardiac output. The
preferential dilatation of
arterioles, as compared to veins, minimizes postural hypotension and
promotes the
increase in cardiac output. HydrALAZINE usually increases renin
activity in plasma,
presumably as a result of increased secretion of renin by the renal
juxtaglomerular cells
in response to reflex sympathetic discharge. This increase in renin
activity leads to the
production of angiotensin II, which then causes stimulation of
aldosterone and
consequent sodium reabsorption. HydrALAZINE also maintains or
increases renal and
cerebral blood flow.
Hy